(30 days)
Not Found
No
The summary describes hardware modifications and standard signal processing for a nuclear medicine imaging system. There is no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No
Explanation: This device is an imaging system designed to detect and image the distribution of radionuclides in the body for diagnostic purposes, not for treating conditions.
Yes
The device produces images depicting the anatomical distribution of radioisotopes in the human body for interpretation by authorized medical personnel, which is a diagnostic function.
No
The device description explicitly details significant hardware components, including a photon radiation detector, mechanical and electrical design changes, a solid-state RIM detector, and associated circuitry for signal processing. While software is mentioned for acquisition, the core functionality relies on physical hardware for image capture.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "imaging the distribution of radionuclides in the body" and producing "images depicting the anatomical distribution of radioisotopes within the human body". This describes an in vivo (within the living body) imaging process, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details a "photon radiation detector" and its components, which are used to capture radiation emitted from within the patient's body. This is consistent with nuclear medicine imaging, not IVD testing which typically involves analyzing biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside of the body, which are hallmarks of IVD devices.
The device is a nuclear medicine imaging system, which is a type of medical imaging equipment used for diagnostic purposes in vivo.
N/A
Intended Use / Indications for Use
The ergo imaging system is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.
Product codes (comma separated list FDA assigned to the subject device)
IYX
Device Description
The proposed changes involve modifications to the 2020tc Imaging System to increase size of the detector head field of view (FOV) from 8"x 8" to 12"x 15". Modifications include mechanical and electrical design changes to support the large field-of-view (LFOV) detector head. The modified device (ergo Imaging System) incorporates Digirad's solid-state RIM detector design, modified with 3mm size pixels required for general purpose planar imaging. The 2020tc Imager detectors currently utilize the same 3mm pixel size.
The detectors used in the modified and predicate device utilize a pixelated, multi-crystal CsI scintillator detector with each pixel optically coupled to a low noise photodiode array. The charge detected from each gamma ray is amplified and processed using an amplifier circuit. The RIM detector design technology is currently used in the Digirad Cardius XPO imager systems with a 6mm pixel size for Cardiac SPECT imaging. The RIM detector has been modified to incorporate a 3mm size pixel required for general planar imaging. The RIM detector design includes electrical and mechanical configurations allowing for field replacement of detector modules and improved system performance (better energy resolution). The updated design of the RIM detector head assembly allows some of the current sub-systems to be moved into the detector head assembly (air dryer) and simplification of others (cooling and power distribution systems).
The modified device uses the 2020tc Imaging System SeeQuanta Acquisition software, with minor modifications required for use with the 3mm pixel size RIM detector modules.
The 2020tc Imager was initially marketed as the Digirad Notebook Imager (K961104), then re-branded as the 2020tc Imaging System (K982855) when it was used in conjunction, with the SPECTour Rotating Chair to obtain SPECT images in patients who are seated in an upright position. The modified device (ergo Imaging System) is a general purpose Nuclear Medicine Imaging device used for planar imaging, the same as the Notebook Imager/20201c Imager when imaging without the rotating chair.
Mentions image processing
The charge detected from each gamma ray is amplified and processed using an amplifier circuit.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photon radiation detector
Anatomical Site
Within the human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical personnel to perform nuclear medicine studies.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Verification and Validation tests were conducted to demonstrate the ergo imaging system functioned as per its specifications. All tests passed with the actual results substantially matching the expected results. The testing shows the system meets the design specifications, which are similar to the predicate device functional specifications. Digirad internal testing and phantom images obtained with the ergo imaging system have demonstrated equivalent efficacy to the predicate devices, and did not raise new questions regarding safety and effectiveness.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and Validation tests were conducted to demonstrate the ergo imaging system functioned as per its specifications. All tests passed with the actual results substantially matching the expected results. The testing shows the system meets the design specifications, which are similar to the predicate device functional specifications. Digirad internal testing and phantom images obtained with the ergo imaging system have demonstrated equivalent efficacy to the predicate devices, and did not raise new questions regarding safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K9641104, K982855, K051549, K070542
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).
0
Appendix 2: 510(k) Summary
A. Sponsor
Digirad Corporation 13950 Stowe Drive Poway, California 92064 Contact Person: Joel Tuckey Tel: (858) 726-1527 Fax: (858) 726-1546
APR 2 3 2010
B. Date Prepared: March 23, 2010
C. Device Name
| Trade Name: | ergo Imaging System |
|---|---|
| Common Name: | Camera, Scintillation (Gamma) |
| Classification Name: | Scintillation (gamma) camera |
| Device Class: | 21CFR 892.1100, Class I |
| Product Code: | IYX |
Cleared/Predicate Devices D.
The ergo Imaging System is substantially equivalent to the following cleared devices:
(1) Notebook Imager (Gamma Camera), cleared on May 28, 1997, under K9641104, and
(2) 2020tc SPECT Imaging System and the SPECTour Chair (SPECT Imaging System), cleared on November 9, 1998 under K982855, and
(3) Cardius-1, Cardius-2, Cardius-3, 2020tc SPECT Imaging System, cleared on July 13, 2005 under K051549, and
(4) Cardius XPO series and 2020tc SPECT Imaging Systems cleared on March 23, 2007 under K070542.
E. Device Description
The proposed changes involve modifications to the 2020tc Imaging System to increase size of the detector head field of view (FOV) from 8"x 8" to 12"x 15". Modifications include mechanical and electrical design changes to support the large field-of-view (LFOV) detector head. The modified device (ergo Imaging System) incorporates Digirad's solid-state RIM detector design, modified with 3mm size pixels required for general purpose planar imaging. The 2020tc Imager detectors currently utilize the same 3mm pixel size.
The detectors used in the modified and predicate device utilize a pixelated, multi-crystal CsI scintillator detector with each pixel optically coupled to a low noise photodiode array. The charge detected from each gamma ray is amplified and processed using an amplifier circuit. The RIM detector design technology is currently used in the Digirad Cardius XPO imager systems with a 6mm pixel size for Cardiac SPECT imaging. The RIM detector has been modified to incorporate a 3mm size pixel required for general planar imaging. The RIM detector design includes electrical and mechanical configurations allowing for field
1
replacement of detector modules and improved system performance (better energy resolution). The updated design of the RIM detector head assembly allows some of the current sub-systems to be moved into the detector head assembly (air dryer) and simplification of others (cooling and power distribution systems).
The modified device uses the 2020tc Imaging System SeeQuanta Acquisition software, with minor modifications required for use with the 3mm pixel size RIM detector modules.
The 2020tc Imager was initially marketed as the Digirad Notebook Imager (K961104), then re-branded as the 2020tc Imaging System (K982855) when it was used in conjunction, with the SPECTour Rotating Chair to obtain SPECT images in patients who are seated in an upright position. The modified device (ergo Imaging System) is a general purpose Nuclear Medicine Imaging device used for planar imaging, the same as the Notebook Imager/20201c Imager when imaging without the rotating chair.
F. Intended Use
The ergo imaging system is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.
The ergo imaging system will be used by trained medical personnel to perform nuclear medicine studies.
G. Technology
The ergo Imaging System utilizes Digirad's solid state detector technology used on other Digirad imaging systems. The LFOV (12" x 15") detector head assembly facilitates being able to image larger areas of the patient with a single acquisition. The changes do not alter the fundamental scientific technology of the predicate device.
H. Testing
Verification and Validation tests were conducted to demonstrate the ergo imaging system functioned as per its specifications. All tests passed with the actual results substantially matching the expected results. The testing shows the system meets the design specifications, which are similar to the predicate device functional specifications. Digirad internal testing and phantom images obtained with the ergo imaging system have demonstrated equivalent efficacy to the predicate devices, and did not raise new questions regarding safety and effectiveness.
I. Conclusion
Testing results demonstrate that the ergo Imaging System meets the specifications and is substantially equivalent to the predicate devices, based on comparisons of intended use and technology, and overall system performance.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is rendered in a blue color. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
OCT 2 1 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Joel Tuckey Vice President QA/RA Digirad Corporation 13950 Stowe Drive POWAY CA 92064
Re: K100838
Trade/Device Name: ergo Imaging System Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) Camera Regulatory Class: II Product Code: IYX Dated: March 23. 2010 Received: March 24, 2010
Dear Mr. Tuckey:
This letter corrects our substantially equivalent letter of April 23, 2010.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
David C. Brown, Ph.D.
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K100838
Device Name: ergo Imaging System
Indications for Use:
The ergo Imaging System is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of
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... は
Robert Lee Bell
(Division Sign-Off
Division of Radiological Devices
Office of In Vitro Diagnostic Device Eraluation and Safety
510K K100838